Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE) (CODE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00890136
Recruitment Status :
First Posted : April 29, 2009
Last Update Posted : October 3, 2017
Johns Hopkins University
National Institute of Environmental Health Sciences (NIEHS)
This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
40 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Both Male and Female 40 years and older
Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema
Cigarette Smoking > 10 pack-years
Age > 40 years
Has not smoked > 1 year
Post BD FEV1/FVC ≤ 70%
Post BD FEV1 (% predicted) 30-80%
Ability and willingness to provide consent
Non- English speaking
Planning to move or live away from the home during the study period
Co-morbid illnesses such as:
Current physician diagnosis of Asthma
Other pulmonary diseases
Systemic disease requiring treatment with immunosuppressive agents
Known alpha-1 antitrypsin deficiency
Occupational exposure with high endotoxin exposure
Within the last 6 months Use of oral corticosteroids